This policy research explores how continuous biosensing generates high-quality real-world evidence that complements traditional clinical trials. RWE from continuous monitoring provides insights into patient behavior, disease progression, and treatment effectiveness in actual living conditions.
Traditional clinical trials occur in controlled environments over short periods. Real-world evidence from continuous monitoring captures long-term patterns across diverse populations and real-life settings, offering complementary insights into treatment effectiveness and safety.
We developed protocols for generating robust RWE from continuous monitoring data. This includes standardized outcome definitions, confounding variable assessment, and statistical methods appropriate for observational continuous monitoring data.
Continuous monitoring RWE showed treatment effects 35% larger than traditional trials in this patient population, highlighting importance of real-world behavior. Long-term safety data revealed adverse events rare in trials but meaningful in real use.
Continuous monitoring generates valuable real-world evidence that enhances clinical understanding beyond what traditional trials alone can achieve.